InVivo Therapeutics has received approval for a significant protocol amendment from the US Food and Drug Administration (FDA) for INSPIRE (InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury).
The amended protocol establishes the objective performance criterion (OPC) for the study as 25% or more of the patients demonstrating an improvement of at least one ASIA (American Spinal Injury Association) Impairment Scale (AIS) grade by six months post-implantation.
Since the INSPIRE study is designed to enrol 20 patients with complete (AIS A) spinal cord injuries (inclusive of the five patients enrolled in the company’s pilot trial) the OPC equates to having five patients convert to any other AIS grade by six months post-implantation. Natural history databases indicate that between 12-16% of patients with complete (AIS A) thoracic injury will spontaneously convert without treatment six months after injury.
Mark Perrin, InVivo’s chairman and chief executive officer, says, “We have made tremendous progress with the FDA over the past year in the design of The INSPIRE Study, and it is very rewarding to complete the design of a study that has the potential to change the standard of care for acute spinal cord injury patients.”